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FDA unveils new portal to boost patient involvement

Jul 9, 2019

The Food and Drug Administration (FDA) has launched a new online service, Request to Connect, offering patients and caregivers a quick, easy and direct link to regulators and a single-entry point for questions and meeting requests.

“The goal is to find better ways of reaching out to patients, understanding what their needs are, to better educate them on how decisions are made and how they can contribute to discussion about their health,” the agency reveals.

“As patient populations and their needs evolve and become increasingly complex, [we] want patients and those who advocate on their behalf to know that our door is open. As a science-based agency, we continue to develop and engage programs that help [the] FDA understand the patient perspective and advance the science of patient input.”

“Co-developed by the patient affairs staff and the medical product centers, the portal will route enquiries to the appropriate medical product center or office to ensure that they are received and responded to in an effective and efficient manner,” says the agency in an announcement.

Request to Connect is part of the agency’s ongoing program of patient involvement, which includes patient-focused drug development meetings and rare disease listening sessions. These are hosted in partnership with the National Organization for Rare Diseases (NORD) and aim to give the agency a better understanding of the needs of the patient community.

“The events are closed to the public and focus on a rare disease for which little is known, and effective treatments are more rare than the disease themselves,” says the FDA in a video.

The human face to scientific decision making

The FDA Patient Representative Program ensures the patient voice is considered when drug approval decisions are being made. Two hundred patient representatives work with the agency across more than 300 diseases and conditions. They give a “human face” to the scientific decision-making process, the video explains.

Other forums include the Patient Engagement Collaboration, in partnership with Duke’s University’s Clinical Trials Transformations Initiative.

The Patient Engagement Advisory Committee meets once a year. During this time, patients and caregivers advise the FDAs Center for Devices and Radiological Health on issues related to medical devices.

“Over the years, we have developed forums, tables at which patients, caregivers, advocates and FDA staff can sit and exchange ideas.

“Each forum provides patients, caregivers and advocates with a seat next to FDA scientists, doctors and researchers. Their input is invaluable.”

Astellas Patient Advocacy is a function within Corporate Affairs at Astellas that focuses on creating, building and maintaining third-party relationships. We serve as a conduit between Astellas and external stakeholders to help improve patient outcomes, improve access issues and address patients’ unmet needs head on.